Evaluating the efficacy and safety of health supplements (including dietary supplements, health-protecting foods, supplementary for subjects with special nutritional regimens, etc.) in Vietnam currently becomes more necessary, especially in the period when there are many health supplements with announced uses that are amplified and exceed their real effects, which can mislead users and cause disrepute for the company. An existing problem is that the majority of dietary supplements lack evidence, and research results demonstrating efficacy and clinical benefit. The announcement of the use of dietary supplements today is almost exclusively based on the announced uses of the ingredients in the product, but there is no research to evaluate specific efficacy. That is the weakness of Vietnam’s health supplements industry when competing with other countries in the world, especially developed countries, which have had many experiences in research, production, and use of health supplements such as the USA and Japan…
In the context of socio-economic development, people’s knowledge, as well as the demand for health care, are increasing. Before deciding to buy and use health supplements, consumers will ask many questions. The most important is “how effective is the product, is there any research confirming its benefit?”. Therefore, setting up clinical trials for health supplements is essential. Currently, Vietnam is in the stage of building and establishing a network of clinical trials of pharmaceuticals and health supplements, creating a legal corridor for people to have access to new effective, and safe products. In Article 4, Circular 43/2014/TT-BYT Guiding the Management of Functional Foods, the Ministry of Health (MOH) emphasized testing the effectiveness of functional foods for human health:
“Products that must be tested for their effects on human health include:
- a) Products that are announced to have the effect of supporting the treatment of diseases;
- b) Products that are announced to have new indications which have not been recognized in other countries in the world;
- c) Products containing new active ingredients that have not yet been approved for use;
- d) Health protection products with formulas different from those already proven by scientific evidence, which is put on the market for the first time;
- e) Products originated herbal or animal that is put on the market for the first time and have different compositions from those of the published traditional medicine products in scientific journals;
- f) Medical nutrition food and food for special dietary, which have not been approved by the competent authority or by the law of the country of origin, certified by the exporting country, the indication and dosing & uses are allowed to be stated on the goods label.”
The clinical trials will provide accurate scientific evidence, ensuring the legal element so that a health supplement product can maximize its effects on human health in preventing recurrence/relapse, development of non-infective chronic diseases, and effectively supporting disease treatment, recovery, and health promotion.
